NCT02252393

Brief Summary

This randomized clinical trial studies intracorporeal or extracorporeal urinary diversion during robotic assisted radical cystectomy in reducing complications in patients with bladder cancer. Radical cystectomy is surgery to remove the entire bladder as well as nearby tissues and organs. After the bladder is removed, urinary diversion (a surgical procedure to make a new way for urine to leave the body) is performed. It is not yet known whether intracorporeal (within the body) or extracorporeal (outside of the body) urinary diversion is a better method in patients with bladder cancer undergoing robotic assisted radical cystectomy.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2015

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2014

Completed
1 year until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 9, 2016

Status Verified

November 1, 2016

Enrollment Period

1.1 years

First QC Date

September 26, 2014

Last Update Submit

November 8, 2016

Conditions

Recurrent Bladder CancerStage 0 Bladder CancerStage I Bladder CancerStage II Bladder CancerUrinary Complications

Outcome Measures

Primary Outcomes (1)

  • Complication rate

    Analyzed using multivariable logistical regression. Descriptions and grading scales found in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for adverse event reporting.

    90 days after surgery

Secondary Outcomes (12)

  • Time to passage of flatus

    Up to 90 days

  • Analgesic requirement (narcotic use)

    Up to 90 days

  • Hospital length of stay

    Up to 90 days

  • Total operating time

    Up to completion of surgery

  • Estimated blood loss

    Up to 90 days

  • +7 more secondary outcomes

Study Arms (2)

Arm I (RARC with IUD)

EXPERIMENTAL

Patients undergo RARC with IUD.

Procedure: robot-assisted laparoscopic surgeryOther: intraoperative complication management/preventionOther: quality-of-life assessment

Arm II (RARC with EUD)

EXPERIMENTAL

Patients undergo RARC with EUD.

Procedure: robot-assisted laparoscopic surgeryOther: intraoperative complication management/preventionOther: quality-of-life assessment

Interventions

robot-assisted laparoscopic surgeryPROCEDURE

Undergo RARC with IUD

Arm I (RARC with IUD)
intraoperative complication management/preventionOTHER

Undergo RARC with IUD

Arm I (RARC with IUD)
quality-of-life assessmentOTHER

Ancillary studies

Also known as: quality of life assessment
Arm I (RARC with IUD)Arm II (RARC with EUD)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Grade G1 - G3 bladder cancer
  • T stage: cTis - T2
  • American Society of Anesthesiologists (ASA) \< 4
  • Informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status 2 or better
  • Hemoglobin (Hgb) \> 8.0 g/dL
  • White blood cell (WBC) \> 2.0 k/uL
  • Platelets \> 50,000
  • Creatinine \< 3.0 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) \< 5.0 x ULN
  • Alanine transaminase (ALT) \< 5.0 x ULN

You may not qualify if:

  • Patient unsuitable for or refusing radical cystectomy
  • T stage ≥ T3 (mass extending outside the bladder)
  • Gross nodal or metastatic disease at presentation (≥ N1, M1)
  • Prior pelvic radiation
  • Prior open or laparoscopic/robotic bladder or prostate surgery
  • Prior colorectal surgery or history of inflammatory bowel disease
  • Body mass index (BMI) ≥ 40
  • ECOG performance status 3 or worse
  • History of coagulopathy or bleeding disorders
  • Chronic steroid use
  • Patients with end stage renal disease (ESRD) and/or on dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Jihad Kaouk

    Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2014

First Posted

September 30, 2014

Study Start

October 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

November 9, 2016

Record last verified: 2016-11